AccessGUDID - DEVICE: NxSTEP (00718175004845)

GUDID

Device Identifier (DI) Information

Brand Name: NxSTEP
Version or Model: 950-484
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 950-484
Company Name: BIODEX MEDICAL SYSTEMS, INC.

Primary DI Number: 00718175004845
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 043833813 *Terms of Use

Device Description: NxSTEP Unweighing System, without Harness

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
61942	Mobile gait rehabilitation system, harness-support	A mobile assembly of battery-powered devices designed to assist a patient with a walking/balance disability (neurological, muscular, cardiovascular, or orthopaedic in origin) to regain lost motor function, by enabling the patient to walk over ground (i.e., not on a treadmill) whilst supported from above. It consists of a mobile rigid framework on electronically-controlled wheels, a patient harness with suspension assembly, and motion sensors; the device senses patient movements and automatically follows the patient. The patient is supported overhead to assist rehabilitation and provide fall protection. It is intended to be used in a clinical setting under professional supervision.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ITJ	Walker, Mechanical

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 536e96b3-028e-41d5-b3f0-3e4fc6597a59
Public Version Date: May 23, 2019
Public Version Number: 1
DI Record Publish Date: May 15, 2019

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: No
Serial Number: Yes
Expiration Date: No
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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